Trial · NCT01625377
A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients
NCT01625377, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2016-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients. Trials, record NCT01625377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01625377
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients
- NCT number
- NCT01625377
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 188 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Liver Transplantation
- Interventions
- tacrolimus, everolimus, Basiliximab, Mycophenolic Acid, Corticosteroids
- First posted
- 2012-06-21
- Last updated
- 2016-04-27
- Other registries' IDs
- eudract:2012-000137-39
- Results first posted
- 2016-04-27
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (Randomization) in Renal Function | Baseline, Week 24 | Change in renal function was measured by change in glomerular filtration rate (GFR). GFR calculated using the abbreviated modification of diet in renal disease (aMDRD) formula. GFR in mL/min/1.73m\^2 for men of non-black ethnicity: 186 \* \[C/88\]\^-1.154 \* \[A\]\^-0.023\*G\*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit. |
| Secondary | Number of Patients With Treatment Failures | At week 12 and week 24 | Incidence of treatment failures, assessed with composite criterion including treated biopsy proven acute rejection (tBPAR) with a rejection activity index (RAI) according to Banff classification \>3, graft loss or death at 6 months. Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft. |
| Secondary | Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR) | at 12 week and 24 week | Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy. |
| Secondary | Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification | at 12 week and 24 week | Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy. The severity of BPAR was categorized as : Mild (Banff grade I, RAI = 4 and 5) Moderate (Banff grade II, RAI = 6 and 7) Severe (Banff grade III, RAI = 8 and 9) Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. |
| Secondary | Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3 | At 24 weeks | Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted. The patients with treated or untreated BPAR having RAI score \> 3 were reported in this end point. |
| Secondary | Number of Patients With Death or Graft Loss | at week 24 | The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft. |
| Secondary | Change From Baseline (Randomization) in Serum Creatinine | Baseline, Week 24 | Change in serum creatinine concentrations from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit. |
| Secondary | Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio | Baseline, week 24 | Change in urine protein/creatinine ratio from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit. |
| Secondary | Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula | Baseline, Week 24 | Creatinine clearance by the Cockcroft-Gault formula is computed in mL/min/1.73m\^2 from the creatinine clearance in mL/min by multiplying it by 1.73 and dividing it by the body surface area Baseline was Day 28 visit. |
| Secondary | Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula | Baseline, Week 24 | Change in glomerular filtration rate was calculated using the MDRD abbreviated formula. GFR in mL/min/1.73m\^2 for men of non-black ethnicity: 186 \* \[C/88\]\^-1.154 \* \[A\]\^-0.023\*G\*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (Randomization) in Renal Function | Baseline, Week 24 | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value a Day 28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data. | mL/min/1.73m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With Treatment Failures | At week 12 and week 24 | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available. | Patients | NUMBER |
| SECONDARY | Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR) | at 12 week and 24 week | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available. | Patients | NUMBER |
| SECONDARY | Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification | at 12 week and 24 week | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available. | Patients | NUMBER |
| SECONDARY | Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3 | At 24 weeks | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available. | Patients | NUMBER |
| SECONDARY | Number of Patients With Death or Graft Loss | at week 24 | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available. | Patients | NUMBER |
| SECONDARY | Change From Baseline (Randomization) in Serum Creatinine | Baseline, Week 24 | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data. | µmol/L | MEAN |
| SECONDARY | Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio | Baseline, week 24 | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom urine protein and creatinine value at day 28 and a posterior value were available. LOCF applied. | mg/mmol | MEAN |
| SECONDARY | Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula | Baseline, Week 24 | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula | Baseline, Week 24 | The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data. | mL/min/1.73m^2 | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (Randomization) in Renal Function | Tacrolimus | -13.29 | Standard Error 2.75 | mL/min/1.73m^2 | |
| Change From Baseline (Randomization) in Renal Function | Everolimus (RAD001) | 1.05 | Standard Error 2.81 | mL/min/1.73m^2 | |
| Number of Patients With Treatment Failures | Tacrolimus | week 12, Treatment failures - NO | 91 | Patients | |
| Number of Patients With Treatment Failures | Everolimus (RAD001) | week 12, Treatment failures - NO | 88 | Patients | |
| Number of Patients With Treatment Failures | Tacrolimus | week 12, Treatment failures - YES | 2 | Patients | |
| Number of Patients With Treatment Failures | Everolimus (RAD001) | week 12, Treatment failures - YES | 2 | Patients | |
| Number of Patients With Treatment Failures | Tacrolimus | week 24, Treatment failures - NO | 89 | Patients | |
| Number of Patients With Treatment Failures | Everolimus (RAD001) | week 24, Treatment failures - NO | 81 | Patients | |
| Number of Patients With Treatment Failures | Tacrolimus | week 24, Treatment failures - YES | 4 | Patients | |
| Number of Patients With Treatment Failures | Everolimus (RAD001) | week 24, Treatment failures - YES | 9 | Patients |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tacrolimus | 95 | |
| Overall Study | STARTED | Everolimus (RAD001) | 93 | |
| Overall Study | Safety Set of Population | Tacrolimus | 94 | |
| Overall Study | Safety Set of Population | Everolimus (RAD001) | 90 | |
| Overall Study | Intent to Treat Population | Tacrolimus | 93 | |
| Overall Study | Intent to Treat Population | Everolimus (RAD001) | 90 | |
| Overall Study | COMPLETED | Tacrolimus | 88 | |
| Overall Study | COMPLETED | Everolimus (RAD001) | 71 | |
| Overall Study | NOT COMPLETED | Tacrolimus | 7 | |
| Overall Study | NOT COMPLETED | Everolimus (RAD001) | 22 |
Source ClinicalTrials.gov
Adverse events228
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tacrolimus | 7 | 94 | |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus (RAD001) | 12 | 90 | |
| other | Leukopenia | Blood and lymphatic system disorders | Tacrolimus | 8 | 94 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus (RAD001) | 10 | 90 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Tacrolimus | 6 | 94 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Everolimus (RAD001) | 4 | 90 | |
| other | Neutropenia | Blood and lymphatic system disorders | Tacrolimus | 14 | 94 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus (RAD001) | 9 | 90 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Tacrolimus | 1 | 94 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Everolimus (RAD001) | 5 | 90 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tacrolimus | ||
| Total, all-cause mortality | Everolimus (RAD001) | ||
| Total, other adverse events | Tacrolimus | 68 | 94 |
| Total, other adverse events | Everolimus (RAD001) | 64 | 90 |
| Total, serious adverse events | Tacrolimus | 28 | 94 |
| Total, serious adverse events | Everolimus (RAD001) | 42 | 90 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tacrolimus vs Everolimus (RAD001): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01625377
GET https://conductscience.org/api/trials/v1/NCT01625377/results?page=2